DGAP-News: Egalet Enters Into Development Collaboration and License Agreement With Shionogi Limited for Abuse-Deterrent Oral Hydrocodone Opioid Product Candidates

| Source: EQS Group AG
DGAP-News: Egalet Corporation /
Egalet Enters Into Development Collaboration and License Agreement
With Shionogi Limited for Abuse-Deterrent Oral Hydrocodone Opioid
Product Candidates

27.11.2013 / 15:32


Egalet Licenses Rights to Preclinical Hydrocodone-Based Product Candidates to
Be Developed Using Egalet's Proprietary Abuse-Deterrent Delivery Technology;
Egalet to Receive Upfront and Milestone Payments Plus Potential Royalties on
Net Sales 

MALVERN, Pa., 2013-11-27 15:32 CET (GLOBE NEWSWIRE) --
Egalet Corporation ('Egalet') announced today that it has entered into a
definitive collaboration and license agreement with Shionogi Limited
('Shionogi') for the development and potential commercialization of multiple
oral abuse-deterrent hydrocodone opioid product candidates using Egalet's
proprietary technology. 

Egalet will receive a $10 million upfront payment from Shionogi and Shionogi
has agreed to purchase up to approximately $15 million in common stock in a
private placement to close concurrently with Egalet's recently filed initial
public offering. Egalet is eligible to receive milestone payments upon
development and approval of products under the agreement, which may exceed $300
million if multiple products are approved. Shionogi will fund all costs
associated with the development of these products. Shionogi will also have
exclusive global rights to commercialize the resulting products. If any
products developed under the collaboration are approved for marketing, Egalet
is eligible to receive tiered royalties, ranging from the mid-single digits to
the low double digits based on the net sales of such products, as well as
sales-based milestone payments that could exceed $100 million based on the
attainment of specified sales thresholds. 

'With their commitment to pain therapeutics and their strong sales and
marketing capabilities, we are pleased to be collaborating with Shionogi for
the development and potential commercialization of abuse-deterrent hydrocodone
products using our proprietary technology,' said Bob Radie, Egalet's President
and Chief Executive Officer. 'We believe this collaboration provides validation
for our proprietary abuse-deterrent drug delivery platform and positions us to
capitalize on our technology, both through the products to be developed under
the collaboration and by enabling us to develop additional opioid candidates
utilizing our platform technology.' 

Stifel acted as exclusive financial advisor to Egalet in this transaction.

About Hydrocodone

Hydrocodone is an opioid agonist used in the treatment of mild to moderate
pain.  It is currently available as a single agent or in combination with other
analgesics, such as acetaminophen (e.g., Vicodin).  Abuse of prescription
opioids has become a national epidemic in the United States. A study funded by
the National Institutes of Health estimates that approximately 8% of the
nation's 12th-graders abused hydrocodone in 2010. There are no abuse-deterrent
hydrocodone single-agent or combination products currently on the market. 

About Shionogi

Shionogi & Co., Ltd., headquartered in Osaka, Japan, has subsidiaries in Europe
(Shionogi Limited), US (Shionogi Inc.), and Asia.  Shionogi & Co., Ltd. is a
major research-driven pharmaceutical company dedicated to placing the highest
value on meeting the medical needs of patients.  In addition, Shionogi & Co.,
Ltd. is engaged in new research in areas such as pain and infectious diseases. 
Contributing to the health of patients around the world through innovative
research and development is Shionogi & Co., Ltd.'s primary goal.  For more
details on Shionogi Limited, please visit www.shionogi.eu. For more details on
Shionogi Inc, please visit www.shionogi.com. For more information on Shionogi &
Co., Ltd., please visit www.shionogi.co.jp. 

About Egalet Corporation

Egalet Corporation is a specialty pharmaceutical company developing and
planning to commercialize proprietary, abuse-deterrent oral products for the
treatment of pain and other indications.  The company has created two distinct
drug delivery systems, each with novel abuse-deterrent features and the ability
to control the release profile of the active pharmaceutical ingredient.  Using
its proprietary platform, Egalet has developed a pipeline of clinical-stage,
opioid-based product candidates in tablet form that are specifically designed
to deter abuse by physical and chemical manipulation, while also providing
tailored release of the active pharmaceutical ingredient.  Our lead product
candidate, Egalet-001, is an abuse-deterrent, extended-release, oral morphine
formulation in development for the treatment of moderate to severe pain.  There
are currently no commercially available abuse-deterrent formulations of
morphine, and we believe that Egalet-001, if approved, would fill a significant
unmet need in the marketplace. Our second product candidate, Egalet-002, is an
abuse-deterrent, extended-release, oral oxycodone formulation in development
for the treatment of moderate to severe pain.  The Egalet technology can be
applied broadly across different classes of pharmaceutical products and can be
used to develop combination products that include multiple APIs with similar or
different release profiles. 

Safe Harbor Statement

Certain statements in this news release regarding future expectations and plans
for future activities may be regarded as 'forward-looking statements.'  These
statements are indicated by the words 'may,' 'will,' 'plans,' 'believes,'
'expects,' 'anticipates,' 'potential,' 'should,' and similar expressions. Such
forward-looking statements involve known and unknown risks, uncertainties, and
other factors that may cause actual results to differ materially from those
projected in the forward-looking statements.  Readers are cautioned not to
place undue reliance on these forward-looking statements, which speak only as
of the date of this release.  Factors that might cause future results to differ
include, but are not limited to, the following: timely and successful discovery
and development by Egalet of abuse-deterrent hydrocodone-based products; the
ability to successfully commercialize any approved abuse-deterred
hydrocodone-based products;  the availability and pricing of third-party
sourced products and materials; the ability to obtain and enforce patents and
other intellectual property rights; the strength of the United States dollar
relative to international currencies, particularly the Japanese yen;
competitive economic and regulatory factors in the pharmaceutical and
healthcare industry; general economic conditions; and other risks and
uncertainties described in Egalet's Registration Statement on Form S-1
originally filed with the Securities and Exchange Commission on October 16,
2013, and the amendments thereto, including those factors discussed under the
caption 'Risk Factors' in such filings.  Egalet does not undertake any
responsibility to revise or update any forward-looking statements contained
herein, except as expressly required by law. 

This announcement is neither an offer to sell nor a solicitation of an offer to
buy any of securities of Egalet, and shall not constitute an offer,
solicitation or sale in any jurisdiction in which such offer, solicitation or
sale is unlawful. 

         CONTACT: Lisa M. Wilson
         In-Site Communications, Inc.
         T: 917-543-9932
         E: lwilson@insitecony.com
News Source: NASDAQ OMX

End of Corporate News


27.11.2013 Dissemination of a Corporate News, transmitted by DGAP - a
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Language:    English             
Company:     Egalet Corporation  
             United States       
End of News    DGAP News-Service  
241988 27.11.2013